Impact of Non-traditional Guitar Group Instruction on Functional Movement and Well-being in Parkinson's Disease Patients

NCT ID: NCT02925065

Last Updated: 2018-10-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

26 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-03-05

Study Completion Date

2018-07-26

Brief Summary

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This controlled prospective cohort study is designed to assess the feasibility and effect of twice-weekly 60 minute non-traditional guitar classes on PD patient's self-reported and measurable outcomes including upper extremity function, motor findings, quality of life, mood, and cognitive findings. 24-30 individuals with PD will be randomly assigned to an early-start and a late-start guitar instruction group. Prior to conducting a larger study, this study seeks to assess the possibility that participation in an instrumental performance activity in a group setting may improve outcomes in PD patients.

Detailed Description

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PROBLEM STATEMENT: Engagement in musical activities has been found to improve symptoms in individuals with Parkinson's disease (PD), and physical therapy and music therapy have been demonstrated as viable non-pharmacological intervention methods that improve motor function in these individuals. Therapeutic instrumental music performance has the attributes of physical, rhythmic and social engagement combined with immediate auditory feedback, and has the potential to bring in additional neuro-rehabilitative effects associated with musical engagement into a treatment design. However, until now, much of the research has focused on the rhythmic aspects of music. Few studies have examined how active and complex engagement with music, such as learning to play an instrument, may help PD patients. Finger-style guitar instruction has the potential to improve bilateral dexterity in addition to other gains reported with music-based interventions in patients with PD.

PURPOSE: The purpose of this pilot controlled prospective cohort study is to assess the feasibility and the effects of non-traditional finger-style guitar classes on the quality of life, motor symptoms, upper extremity function, cognition, mood and social participation in individuals with PD.

HYPOTHESIS: The investigators hypothesize that a 6-week bi-weekly finger-style guitar group intervention (12 sessions in total) in addition to usual and routine treatment will be a feasible intervention in patients with Parkinson's Disease (PD), and both immediate and delayed start groups, of PD patients who participate in a twice-weekly non-traditional guitar class training for 6 weeks will have unchanged or improved upper extremity function and dexterity, improved quality of life and mood.

IMPORTANCE: The estimated overall prevalence of PD in the world is 315 per 100,000 individuals overall, and about 2 per 100 individuals 60 years of age or older, with higher estimates for older individuals living in North America, Europe and Australia. PD prevalence in the United States is projected to rise by 77% between 2010 and 2030. Music and rhythm-based interventions are noninvasive, patient-oriented techniques that lack side effects. The guitar is the most popular played instrument in the U.S, and it is the principal instrument of choice for music therapists. It is affordable and portable, with easy access to commercial instruction. Non-traditional engagement in finger-style music making on the guitar may have a broad impact on PD by improving the quality of functional upper extremity movements, decreasing the amplitude of involuntary movements, increasing social and cognitive participation in activities of daily living, and improving quality of life.

Conditions

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Parkinson's Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Participants will be randomly assigned to early-start or late start guitar groups. Following baseline assessment week, the early-start group will receive twice-weekly non traditional guitar instruction for 6 weeks. The late-start guitar group will receive same intervention after the early-start group complete their 6 week instruction. Study assessments will be conducted during week 7 and week 14. Follow up assessment will be conducted in week 20.
Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Investigators

Study Groups

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Early-start guitar instruction group

A 6 week twice-weekly non-traditional group guitar instruction will be implemented in addition to usual treatment between weeks 1-6 of the study.

Group Type EXPERIMENTAL

Non-traditional group guitar instruction

Intervention Type OTHER

A 6-week curriculum for non-traditional training in finger-style guitar has been developed with rhythmic and goal oriented upper extremity and finger movements. Guitar group intervention will be implemented at the Towson campus of the Peabody Preparatory. Intervention approaches will include rhythmic digital grip with finger isolation, goal directed rhythmic reach on the fret-board and rhythmic alternating tap-like digit and hand movements on the guitar. Participants will be provided with the instruments in the group setting without expectation of practice at home.

Delayed-start guitar instruction group

A 6 week twice-weekly non-traditional group guitar instruction will be implemented in addition to usual treatment between weeks 8-13 of the study.

Group Type EXPERIMENTAL

Non-traditional group guitar instruction

Intervention Type OTHER

A 6-week curriculum for non-traditional training in finger-style guitar has been developed with rhythmic and goal oriented upper extremity and finger movements. Guitar group intervention will be implemented at the Towson campus of the Peabody Preparatory. Intervention approaches will include rhythmic digital grip with finger isolation, goal directed rhythmic reach on the fret-board and rhythmic alternating tap-like digit and hand movements on the guitar. Participants will be provided with the instruments in the group setting without expectation of practice at home.

Interventions

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Non-traditional group guitar instruction

A 6-week curriculum for non-traditional training in finger-style guitar has been developed with rhythmic and goal oriented upper extremity and finger movements. Guitar group intervention will be implemented at the Towson campus of the Peabody Preparatory. Intervention approaches will include rhythmic digital grip with finger isolation, goal directed rhythmic reach on the fret-board and rhythmic alternating tap-like digit and hand movements on the guitar. Participants will be provided with the instruments in the group setting without expectation of practice at home.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Adult patients (age 18-89) with idiopathic PD diagnosis according to the United Kingdom (UK) Brain Bank Criteria with bilateral motor symptoms.
* Hoehn and Yahr Stages 1-3.
* MoCA score \>24 to screen out patients with dementia.

Exclusion Criteria

* Prior exposure to guitar training.
* History of prior trauma of the brain or upper extremities.
* Inability to personally consent to study.
* Inability or unwillingness to participate in twice weekly classes for 6 weeks.
* Agitation or hallucinations.
Minimum Eligible Age

18 Years

Maximum Eligible Age

89 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Johns Hopkins University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Serap E Bastepe-Gray, MD, MM, MsOT

Role: PRINCIPAL_INVESTIGATOR

Johns Hopkins University

Alexander Pantelyat, MD

Role: PRINCIPAL_INVESTIGATOR

Johns Hopkins University

Locations

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Johns Hopkins University (Peabody Institute & Department of Neurology)

Baltimore, Maryland, United States

Site Status

Countries

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United States

References

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Altenmuller E, Marco-Pallares J, Munte TF, Schneider S. Neural reorganization underlies improvement in stroke-induced motor dysfunction by music-supported therapy. Ann N Y Acad Sci. 2009 Jul;1169:395-405. doi: 10.1111/j.1749-6632.2009.04580.x.

Reference Type BACKGROUND
PMID: 19673814 (View on PubMed)

Austin D, Jimison H, Hayes T, Mattek N, Kaye J, Pavel M. Measuring motor speed through typing: a surrogate for the finger tapping test. Behav Res Methods. 2011 Dec;43(4):903-9. doi: 10.3758/s13428-011-0100-1.

Reference Type BACKGROUND
PMID: 21494919 (View on PubMed)

Benoit CE, Dalla Bella S, Farrugia N, Obrig H, Mainka S, Kotz SA. Musically cued gait-training improves both perceptual and motor timing in Parkinson's disease. Front Hum Neurosci. 2014 Jul 7;8:494. doi: 10.3389/fnhum.2014.00494. eCollection 2014.

Reference Type BACKGROUND
PMID: 25071522 (View on PubMed)

Bloem BR, de Vries NM, Ebersbach G. Nonpharmacological treatments for patients with Parkinson's disease. Mov Disord. 2015 Sep 15;30(11):1504-20. doi: 10.1002/mds.26363. Epub 2015 Aug 14.

Reference Type BACKGROUND
PMID: 26274930 (View on PubMed)

de Dreu MJ, van der Wilk AS, Poppe E, Kwakkel G, van Wegen EE. Rehabilitation, exercise therapy and music in patients with Parkinson's disease: a meta-analysis of the effects of music-based movement therapy on walking ability, balance and quality of life. Parkinsonism Relat Disord. 2012 Jan;18 Suppl 1:S114-9. doi: 10.1016/S1353-8020(11)70036-0.

Reference Type BACKGROUND
PMID: 22166406 (View on PubMed)

Dorsey ER, George BP, Leff B, Willis AW. The coming crisis: obtaining care for the growing burden of neurodegenerative conditions. Neurology. 2013 May 21;80(21):1989-96. doi: 10.1212/WNL.0b013e318293e2ce. Epub 2013 Apr 24.

Reference Type BACKGROUND
PMID: 23616157 (View on PubMed)

Francois C, Grau-Sanchez J, Duarte E, Rodriguez-Fornells A. Musical training as an alternative and effective method for neuro-education and neuro-rehabilitation. Front Psychol. 2015 Apr 28;6:475. doi: 10.3389/fpsyg.2015.00475. eCollection 2015.

Reference Type BACKGROUND
PMID: 25972820 (View on PubMed)

Goetz CG, Tilley BC, Shaftman SR, Stebbins GT, Fahn S, Martinez-Martin P, Poewe W, Sampaio C, Stern MB, Dodel R, Dubois B, Holloway R, Jankovic J, Kulisevsky J, Lang AE, Lees A, Leurgans S, LeWitt PA, Nyenhuis D, Olanow CW, Rascol O, Schrag A, Teresi JA, van Hilten JJ, LaPelle N; Movement Disorder Society UPDRS Revision Task Force. Movement Disorder Society-sponsored revision of the Unified Parkinson's Disease Rating Scale (MDS-UPDRS): scale presentation and clinimetric testing results. Mov Disord. 2008 Nov 15;23(15):2129-70. doi: 10.1002/mds.22340.

Reference Type BACKGROUND
PMID: 19025984 (View on PubMed)

Grau-Sanchez J, Amengual JL, Rojo N, Veciana de Las Heras M, Montero J, Rubio F, Altenmuller E, Munte TF, Rodriguez-Fornells A. Plasticity in the sensorimotor cortex induced by Music-supported therapy in stroke patients: a TMS study. Front Hum Neurosci. 2013 Sep 3;7:494. doi: 10.3389/fnhum.2013.00494. eCollection 2013.

Reference Type BACKGROUND
PMID: 24027507 (View on PubMed)

Gummesson C, Ward MM, Atroshi I. The shortened disabilities of the arm, shoulder and hand questionnaire (QuickDASH): validity and reliability based on responses within the full-length DASH. BMC Musculoskelet Disord. 2006 May 18;7:44. doi: 10.1186/1471-2474-7-44.

Reference Type BACKGROUND
PMID: 16709254 (View on PubMed)

Hughes AJ, Daniel SE, Kilford L, Lees AJ. Accuracy of clinical diagnosis of idiopathic Parkinson's disease: a clinico-pathological study of 100 cases. J Neurol Neurosurg Psychiatry. 1992 Mar;55(3):181-4. doi: 10.1136/jnnp.55.3.181.

Reference Type BACKGROUND
PMID: 1564476 (View on PubMed)

Nasreddine ZS, Phillips NA, Bedirian V, Charbonneau S, Whitehead V, Collin I, Cummings JL, Chertkow H. The Montreal Cognitive Assessment, MoCA: a brief screening tool for mild cognitive impairment. J Am Geriatr Soc. 2005 Apr;53(4):695-9. doi: 10.1111/j.1532-5415.2005.53221.x.

Reference Type BACKGROUND
PMID: 15817019 (View on PubMed)

Peto V, Jenkinson C, Fitzpatrick R. PDQ-39: a review of the development, validation and application of a Parkinson's disease quality of life questionnaire and its associated measures. J Neurol. 1998 May;245 Suppl 1:S10-4. doi: 10.1007/pl00007730.

Reference Type BACKGROUND
PMID: 9617716 (View on PubMed)

Pohl P, Dizdar N, Hallert E. The Ronnie Gardiner Rhythm and Music Method - a feasibility study in Parkinson's disease. Disabil Rehabil. 2013;35(26):2197-204. doi: 10.3109/09638288.2013.774060. Epub 2013 Mar 12.

Reference Type BACKGROUND
PMID: 23480646 (View on PubMed)

Proud EL, Miller KJ, Bilney B, Balachandran S, McGinley JL, Morris ME. Evaluation of measures of upper limb functioning and disability in people with Parkinson disease: a systematic review. Arch Phys Med Rehabil. 2015 Mar;96(3):540-551.e1. doi: 10.1016/j.apmr.2014.09.016. Epub 2014 Oct 7.

Reference Type BACKGROUND
PMID: 25301441 (View on PubMed)

Pringsheim T, Jette N, Frolkis A, Steeves TD. The prevalence of Parkinson's disease: a systematic review and meta-analysis. Mov Disord. 2014 Nov;29(13):1583-90. doi: 10.1002/mds.25945. Epub 2014 Jun 28.

Reference Type BACKGROUND
PMID: 24976103 (View on PubMed)

Raglio A. Music Therapy Interventions in Parkinson's Disease: The State-of-the-Art. Front Neurol. 2015 Aug 31;6:185. doi: 10.3389/fneur.2015.00185. eCollection 2015. No abstract available.

Reference Type BACKGROUND
PMID: 26379619 (View on PubMed)

Rochester L, Baker K, Hetherington V, Jones D, Willems AM, Kwakkel G, Van Wegen E, Lim I, Nieuwboer A. Evidence for motor learning in Parkinson's disease: acquisition, automaticity and retention of cued gait performance after training with external rhythmical cues. Brain Res. 2010 Mar 10;1319:103-11. doi: 10.1016/j.brainres.2010.01.001. Epub 2010 Jan 11.

Reference Type BACKGROUND
PMID: 20064492 (View on PubMed)

Schneider S, Schonle PW, Altenmuller E, Munte TF. Using musical instruments to improve motor skill recovery following a stroke. J Neurol. 2007 Oct;254(10):1339-46. doi: 10.1007/s00415-006-0523-2. Epub 2007 Jan 27.

Reference Type BACKGROUND
PMID: 17260171 (View on PubMed)

Van Vugt FT, Ritter J, Rollnik JD, Altenmuller E. Music-supported motor training after stroke reveals no superiority of synchronization in group therapy. Front Hum Neurosci. 2014 May 20;8:315. doi: 10.3389/fnhum.2014.00315. eCollection 2014.

Reference Type BACKGROUND
PMID: 24904358 (View on PubMed)

Hartigan, B. J., & Sarrafian, S. K. (2004). Kinesiology and functional characteristics of upper limb. In D. G. Smith, J. W. Michael, & J. H. Bowker (Eds.), Atlas of amputations and limb deficiencies: surgical, prosthetic, and rehabilitation principles (3rd Edition ed., pp. 101-116). Rosemont, IL: American Academy of Orthopaedic Surgeons.

Reference Type BACKGROUND

Sheikh J.I., & Yesavage J.A. (1986): Geriatric Depression Scale (GDS): Recent evidence and development of a shorter version. In: Brink TL, editor. Clinical Gerontology: A Guide to Assessment and Intervention. Binghampton,NY: The Haworth Press. 165-173.

Reference Type BACKGROUND

Richard K Miller and Associates. (2012). The 2012-2013 Leisure Market Research Handbook. Loganville, GA: Richard K. Miller and Associates.

Reference Type BACKGROUND

Other Identifiers

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IRB00091797

Identifier Type: -

Identifier Source: org_study_id

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